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Abstract:
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Traditional oncology trials are expensive, take a long time, and suffer from high failure rates. With cancer being one of the leading causes of death worldwide, there is an increasingly urgent need to improve current oncology drug development. Adaptive seamless Phase II/III designs hold great promise as they can accelerate the decision-making. Most literature discusses trial adaptions by using the same endpoint for both stages in the seamless designs. However, in oncology, the Phase III endpoint is usually a clinical endpoint, i.e. OS, which takes long time to observe. Use of the clinical endpoint for adaptive decision may delay the adaptation and make seamless designs less appealing. In this presentation, we would like to address the following two issues: 1) how to incorporate intermediate endpoint (e.g. PFS or ORR) data into the decision criteria; 2) how to derive objective adaption criteria from a benefit-cost ratio perspective to streamline the decision making process. This work is illustrated on real design examples in the oncology therapeutic area.
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